International safety notice
The overseas manufacturer has confirmed that the pediatric SMART pad cartridge (HeartStart HS1 pad) contains The film sticker that encloses the pad was mistakenly printed with an image of an adult when it should have been an image of a child. identified one lot that may contain a small number of affected pediatric SMART pad cartridges. I did. The pad itself is a normal pediatric pad. When you receive it, the picture on the package bag that contains it is also the correct picture of a child. Regarding the pediatric SMART Pad Cartridge, there was a mistake in the film seal enclosing the pad. To avoid confusion for users of lots that may contain items with human images printed on them, In addition to providing warning information to users of the lot, we will also provide information on pediatric SMART pads of the target lot on the market. I decided to replace the cartridge.
Japan / PMDA Recalls · JPN · Mar 3, 2022
Key facts
| Title | The overseas manufacturer has confirmed that the pediatric SMART pad cartridge (HeartStart HS1 pad) contains The film sticker that encloses the pad was mistakenly printed with an image of an adult when it should have been an image of a child. identified one lot that may contain a small number of affected pediatric SMART pad cartridges. I did. The pad itself is a normal pediatric pad. When you receive it, the picture on the package bag that contains it is also the correct picture of a child. Regarding the pediatric SMART Pad Cartridge, there was a mistake in the film seal enclosing the pad. To avoid confusion for users of lots that may contain items with human images printed on them, In addition to providing warning information to users of the lot, we will also provide information on pediatric SMART pads of the target lot on the market. I decided to replace the cartridge. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Manufacturer | Philips Japan Co., Ltd. |
| Models | Y111220-01, M5072A |
| Date | Mar 3, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1